Clamps for receiving collapsible resilient tubing are well known and have been in use for a number of years. They hold an important role in controlling the flow of various fluids and gases transported in tubing, particularly medical tubing. The mode of operation for the majority of tubing clamps is to pinch the tubing in such a manner as to collapse the inner lumen of the tubing. Clamps that provide varying degrees of lumen collapse are used to regulate the flow of the fluids and gases through the tubing. Still other clamps are designed to allow either full flow through the tubing or to completely collapse the lumen to fully halt fluid or gas flow. Furthermore, the mechanism of closure in the majority of these clamps is reversible; that is to say, the clamp may be closed and opened multiple times as needed. However, in certain applications, particularly of a medical nature, a single-use clamp that for all intents and purposes is non-reopenable is desirable. That is, by non-reopenable is meant that once closed the clamp cannot be reopened under ordinary use without application of a major force that may destroy the clamp through its application.
Tubing is widely used in many scientific, industrial, and medical applications. This tubing is typically a component of more complex assemblies that include disposable sets for apheresis systems, renal dialysis systems, and other medical devices. These disposable sets are typically pre-manufactured and assembled with various other components including bags, filters, and needles interconnected by the tubing. By virtue of their design, many of the clamps in current-day use require the tubing to be threaded through the clamp prior to the addition of the afore-mentioned components. This design and assembly process is necessary to ensure that the clamp remains in the predetermined location on the disposable set throughout sterilization, packaging, transportation, and final use and to ensure that the tubing remain in a proper orientation for clamp closure and subsequent tube sealing.
The process of use for many of the disposable sets requires the user to disconnect one or more sub-assemblies from the whole disposable set during or after the procedure. This act typically requires the sealing of the tubing leading to this sub-assembly to ensure a complete seal. Conventional practice is to use a radio frequency welder to collapse and, by virtue of radio frequency-generated heat, bond the tubing's inner lumen to create a complete seal. As a supplemental measure of safety, a clamp of conventional design may also be engaged on the tubing to create an additional, non-permanent or reopenable seal.
In certain countries however, governmental regulations pertaining to blood collection and other medical procedures have dictated that while the aforementioned disposable set is connected to a patient, or donor of blood, typically by means of one or more needles, a radio frequency welder may not be used to seal any tubing. These regulations have created a need for a mechanical means or method of sealing the tubing in a non-reopenable manner. Furthermore, since the medical or blood collection practitioner determines at which location the tubing is to be sealed, a need for a clamp that may be inserted onto the tubing or relocated from the assembled location post-manufacture also exists.
U.S. Pat. No. 6,644,618 to Balbo discloses a fast-fit clamp for regulating flow along flexible tubing, in particular for medical use. This clamp possesses two holes facing outwards to allow edgewise insertion and removal of tubing into the clamp. U.S. Design Pat. No. D465,843 to Guala further discloses a clamp for flexible medical lines.
A need exists for a clamp that may be easily placed on the tubing during or after the disposable set assembly process, remain in contact with the tubing throughout sterilization, packaging, transportation, and other handling procedures, and for non-reopenably sealing in a mechanical manner a given section of tubing.